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Method of and system for security and privacy protection in medical forms

Method of and system for security and privacy protection in medical forms description/claims

A claim of priority is made to U.S. Provisional Patent Application Ser. No. 60/825,329, entitled Method and System for Security and Privacy Protection in Medical Forms, filed Sep. 12, 2006 as well as to Canadian patent Application No. 2,559523 filed Sep. 12, 2006.

The present invention relates to electronic medical forms and, in particular, to a method of and system for security and privacy protection in medical forms.

Forms, whether paper or electronic, are commonly used in the collection of data. The generation and management of forms used in medical activities, such as pharmaceutical trials, is known for being particularly costly and consuming considerable human resources due to their unique requirements.

Medical forms are typically completed by subject and/or their caregivers, and circulated through a number of different parties, such as data entry clerks, data analysis consultants, Internet Service Providers (ISPs), hospitals, pharmaceutical companies, government regulators and the like. Medical forms often contain highly sensitive data requiring that certain data never be accessible to certain other parties, and possibly all parties other than one who entered the sensitive data. There is currently no system available that provides the functionality to protect such sensitive data. There are systems which provide security in the form of SSL connections from the client to the server, and enforce good security practices, but these systems do not distinguish between the different data.

There is therefore a need for an improved method of and system for security protection in medical forms.

It is an object of the invention to provide a method of and system for security and privacy protection in medical forms, which obviates or mitigates at least one of the disadvantages described above.

The invention provides a medical form system and method that allows clients dealing with highly sensitive data to ensure that particular data entered is never accessible to certain other parties (or all other parties). In the preferred embodiment, this is done by encrypting and decrypting certain data only on the client and preventing decryption of the data on the server-side.

As noted in the Background, other systems do provide security in the form of SSL connections from the client to the server and enforce good security practices, but they do not provide client-side encryption.

This document discusses the requirements and the high-level software design specifications necessary to provide client-side encryption operational in a medical form system such as the ClinicalAnalytics (CA) software version 3.0 available from TrialStat Corporation. The feature set of this system includes: User Management, Key Management, Form/Question Designer, Renderer and Database Requirements.

This summary of the invention does not necessarily describe all features of the invention.

These and other features of the invention will become more apparent from the following description in which reference is made to the appended drawings wherein:

FIG. 1 presents a flow chart of a method of client-side encryption key management, in accordance with an embodiment of the present invention;

FIG. 2 presents a flow chart of a method of client-side encryption data flow, in accordance with an embodiment of the present invention;

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